Test domiciliare per la diagnosi integrata di infezione da SARS-CoV-2

[Autom. eng. transl.] The pandemic spread of the Covid-19 disease requires an enormous effort to identify individuals who have already come into contact with the virus or are still carriers of the infection even among paucis- or asymptomatic individuals. In the face of this need, the current diagnostic capacities appear to be strongly underpowered on a world scale1. The invention provides for the development of a quick and simple diagnostic test capable of detecting the presence of the SARS-CoV-2 virus and specific secretory immunoglobulins of the IgA class (sIgA) in the saliva / sputum of the proband. The test must be conceived as a home test operated directly by the proband and interpreted by the doctor through simple photographic documentation or a dedicated App. The detection of the virus is based on an agglutination test in salivary fluid of colored Latex Agglutination Test, previously sensitized with an antibody (monoclonal) against the viral Spike Protein (S1), on a glass surface or paper; the revelation can take place within a few minutes to the naked eye. The abundance and repetitiveness of the target antigen on the SARS-CoV-2 surface make this virus particularly effective as an agglutinating agent. For the detection of anti-SARS-CoV-2 sIgA in the same type of sample, an immunochromatographic reaction on a strip is used (Lateral flow test) similar to that commonly used for the qualitative detection of specific IgG and IgM in blood samples; in this case anti-IgA immunoglobulins are immobilized on the "capture line".